11+ ISO 13485 Jobs in Pune | ISO 13485 Job openings in Pune

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

Looking for an experienced Product Manager to work in abroad countries who is passionate about building products that customers love. You will join a dynamic and fast-paced environment and work with cross-functional teams to design, build and roll-out products that deliver the company’s vision and strategy.

Key Responsibilities:

Product Strategy and Vision:

• Develop and communicate a product vision and strategy aligned with the company's overall business objectives.
• Conduct market research, gather customer feedback, and analyze trends to inform the product roadmap.
• Define product goals and key performance indicators (KPIs) to track success.

Product Roadmap:

• Create and maintain a detailed product roadmap, setting priorities based on customer needs, business goals, and resource constraints.
• Balance short-term needs with long-term vision and strategic goals.

Cross-functional Collaboration:

• Work closely with engineering, design, and marketing teams to ensure successful product development and launch.
• Facilitate communication between stakeholders, ensuring everyone is aligned on product requirements, timelines, and goals.

Product Development:

• Write clear and actionable product requirements (PRDs) and user stories.
• Define features, prioritize enhancements, and manage the product backlog.
• Ensure the product development process is efficient and follows Agile or other relevant methodologies.

Customer Focus:

• Conduct user research, surveys, and interviews to understand customer pain points and gather feedback.
• Analyze data and product usage to identify opportunities for improvement or new features.
• Develop customer personas and use cases to guide product decisions.

Go-to-Market Strategy:

• Work with the marketing and sales teams to create product launch strategies, including pricing, messaging, and promotional campaigns.
• Train internal teams on product features and benefits to support successful product adoption.

Lifecycle Management:

• Oversee the product's life cycle, from ideation and design through to release, iteration, and eventual retirement.
• Monitor product performance, gather user feedback, and drive continuous improvement.

Stakeholder Management:

• Serve as the primary point of contact for product-related queries across the organization.
• Present product updates, progress, and results to senior leadership and stakeholders.

Job Title: Business Development Manager (B2B Sales - Fintech & NBFCs)

Company Name: Briidea Innoventures

Location: Pune (Baner)

Employment Type: Full-time

Experience Required: 2-5 years in B2B sales (Fintech/NBFC experience preferred)

Job Overview:

We are seeking a Business Development Manager with prior experience in B2B

sales within the fintech and NBFC domain, particularly in solutions such as Loan

Origination Software (LOS), eNACH systems, Core Banking Software (CBS), and

other financial technology products. The ideal candidate will be responsible for

identifying new business opportunities, engaging with key decision-makers,

driving product sales, and ensuring strong follow-ups for successful deal

closures.

If you have a passion for fintech sales, a deep understanding of NBFCs, Cooperatives,

and financial institutions, and a strong track record in software sales, we invite you to

be a part of our growing team.

Key Responsibilities:

● B2B Sales & Client Acquisition: Proactively identify and reach out to potential

clients in NBFCs, Cooperative Banks, and Schools to generate new business

opportunities.

● Industry-Specific Sales Expertise: Leverage previous experience in selling

fintech products like Loan Origination Software (LOS), eNACH solutions,

Core Banking Software (CBS), or other financial software solutions to

establish credibility and drive conversions.

● Sales Calls & Meetings: Conduct high-impact sales calls, schedule meetings

with senior stakeholders, and present tailored product demonstrations.

● Sales Pipeline & Lead Management: Develop and maintain a structured sales

pipeline, ensuring strong follow-ups with both new and existing clients.

● Product Positioning & Negotiations: Understand client pain points and

propose tailored solutions while managing pricing discussions and contract

negotiations.

● Market Research & Competitive Analysis: Stay updated on market trends,

competitor offerings, and emerging fintech solutions to refine sales strategies.

● CRM & Reporting: Maintain accurate records of sales interactions, pipeline

status, and deal progress using CRM tools.

● Cross-Team Collaboration: Work closely with marketing, product, and technical

teams to align sales strategies and ensure a seamless onboarding experience for

new clients.

Required Skills & Qualifications:

● Education: Bachelor’s or MBA.

● Experience: 2-5 years in B2B sales within the fintech domain, preferably in

selling solutions such as Loan Origination Software (LOS), eNACH, Core

Banking Software (CBS), or digital payment systems to NBFCs,

cooperatives, and financial institutions.

● Industry Knowledge: Strong understanding of NBFCs, Cooperative Banks,

financial lending processes, and digital payment ecosystems.

● Languages: Proficiency in English, Hindi, and Marathi is required.

● Technical Skills: Familiarity with CRM tools, Excel, PowerPoint, and B2B

sales automation tools.

● Communication & Negotiation: Exceptional verbal and written communication

skills, with the ability to engage and persuade senior decision-makers.

● Target-Driven Approach: Proven ability to meet and exceed sales targets

through structured sales strategies.

● Presentation & Client Engagement: Ability to deliver compelling sales

presentations and product demonstrations to key stakeholders.

Why Join Us?

● Work with a fast-growing fintech company catering to the NBFC, Cooperative

Banking, and financial technology sector.

● Opportunity to work with industry leaders and expand your network in the

financial ecosystem.

● Competitive salary, performance-based incentives, and career growth

opportunities.

Our Requirement

• Hands on experience in developing test codes using Python and Pytest frameworks for a minimum of 3 years
• Experience in writing test cases for embedded software for a minimum of 1 years
• Experience with Agile Software Workflows such as Scrum
• Experience with Git, Jira and Confluence
• Should be an expert in Python
• Hand on experience with OOPS
• Strong communication skills
• Hands-on experience in API testing & developing automation test script for mobile or tablet devices using Appium
• Ability to identify new testing techniques and tools
• Excellent problem-solving skills
• Excellent team player and exhibit a positive attitude
• Strong collaboration, oral and written skills

Preferred Skills:

• Strong understanding of Bluethooth, BLE, understanding of WiFi (802.11a/b/g/n)
• Ability to propose new ideas on how to improve customer satisfaction and quality of product
• Ability to carefully examine requirements and specifications to anticipate quality issues and provide timely feedback when specifications are incomplete or inaccurate
• Experience testing Firmware is plus
• Develop and implement unit and integration test cases and scripts for embedded firmware

• Required Educational Qualifications: Minimum B.E/B.Tech with 60% in academics.
• Min. Experience Required: 8 years.
• Should be able to join immediately or within 15 days

• Plan, monitor and execute organic Social media growth strategies on all relevant social media platforms for the company and its clients.
• Excellent and confident communicator to be able to understand and convey the strategies, and plan to the client and internal team.
• Be actively involved in SEO efforts
• Write content for marketing and website
• Collaborate with designers to improve user experience
• Measure performance of digital marketing efforts using a variety of Web analytics tools (Google Analytics)
• Acquire insight into online marketing trends and keep strategies up-to-date
• Developing and optimizing quality paid advertising campaigns across various networks such as Google Ads & Google Shopping, Facebook Ads, Instagram, LinkedIn and more. TikTok & Snapchat Ads are a bonus.

• Skills and experience in creative content writing (Important)
• Fair understanding of digital marketing concepts and best practices
• Working knowledge of Internet and SAAS tools like Google Sheets, Google Slides, etc
• Exposure to SEO concepts
• Exposure to web analytics tools (e.g. Google Analytics, etc)
• Analytical mindset and critical thinking
• Excellent communication and interpersonal skills

1.   In-Depth knowledge and experience with C# .NET Core are must.

2.   Experience in working with API Gateways, REST, SOAP, OAuth, SAML.

3.   Experience inworking with Kafka based environment.

4.   Microservices and Event driven Architecture (with a focus on cloud).

5.   Experience and understanding of OOPS and SOLID design principals.

6.   Well verse with Design Patterns.

7.   Familiarity with Azure and AWS offerings.

8.   Understanding of Relational and NoSQL databases SQL Server, Azure SQL, MongoDB, Elastic.

9.   Familiarity with the .NET framework

10. Familiar with various design and architectural patterns

11. Knowledge of concurrency patterns in C#

12. A willingness to get trained and work on cutting edge technologies like React, Node etc.

13. Understanding fundamental design principles behind a scalable application

14. Implementing automated testing platforms and unit tests

15. Proficient understanding of code versioning tools Git

Familiarity with CICD tools, JIRA, Azure devops etc

Mandatory Skills: Exp in anyone MNC framework (Laravel/Codeigniter/CakePHP)

Roles and Responsibilities:

1. As a PHP Developer, you will be responsible for developing and coding all server-side logic using the CakePHP framework.
2. Writing back-end code and building efficient PHP modules.
3. Understand existing software products and contribute towards improving it.

• Computer assembling and dis -assembling.
• Hardware troubleshooting of desktop, laptop, server machine.
• Microsoft Windows Servers (2008,2012, 2016 ) operating system installation and troubleshooting
• Microsoft Windows ( XP, 7, 8, 10) operating system installation and troubleshooting.
• Various email client installation and troubleshooting.
• Development software (.Net Framework, MS SQL server / client, Visual studio) installation and troubleshooting.
• Linux ( Ubuntu, CentOS ) installation and troubleshooting. ( Mandatory )
• Various software installations on linux platform.
• Network LAN and WAN troubleshooting.
• VPN management
• Knowledge of Virtualization